OECD Unique Identifier details

SYN-BTØ11-1

Commodity:

Corn / Maize

Traits:

Glufosinate tolerance,Lepidoptera resistance

Australia

Name of product applicant:

Novartis Seeds Pty Ltd

Summary of application:

Novartis Seeds Pty. Ltd. have made an application to ANZFA to amend Standard A18 of the Australian Food Standard Code, to include food derived from corn that has been genetically modified for protection against insects, specifically the European corn borer (ECB) and tolerant to the herbicide glufosinate ammonium. The corn is referred to as ‘Bt-ll corn’.

Protection against the European corn borer is achieved through the expression in the plant of a modified, truncated version of the cry1A(b) gene which produces a nature identical insecticidal protein, CryIA(b). Cry1A(b) is produced naturally by the spore-forming soil bacterium Bacillus thuringiensis kurstaki strain HD-1 (B.t.k.).

Tolerance to the herbicide glufosinate ammonium is achieved through the expression of the pat gene, which produces the enzyme, phosphinothricin acetyl transferase (PAT) that chemically modifies the herbicide, thus rendering it inactive.

Bt-11 corn has been crossed into both maize and sweet corn varieties. Maize varieties are generally classified into flint, pop, dent and flour lines based on the hardness of the kernel. Flint varieties are preferred by dry millers for flour, grits and meal based products such as cereals and dent varieties are preferred by wet millers for starch and starch based products such as high fructose corn syrup. Corn oil may be produced from the germ of all varieties. Fermentation ofcereal grains is also used for beverage and alcohol production.

A wide variety of food products are derived from the genetically modified corn including highly processed corn-based food ingredients such as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Maize starch is also used by the food industry for the manufacture of dessert mixes and canned foods. Corn-based ingredients can also be processed into breakfast cereals, baking products, extruded confectionary and corn chips. As well as these highly processed foods, foods produced from sweet corn varieties may be
consumed as fresh, canned or frozen corn or dehydrated in powder form.

Upload:

Date of authorization:

30/08/2001

Scope of authorization:

Food

Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.
The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology.
Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply.
An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods.
The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook).
Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.

FSANZ does not:
Separately assess food from stacked event lines where food from the GM parents has already been approved;
Mandate notification of stacked events by developers;
Notify the public of stacked event ‘approvals’;
List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):

The corn Bt 11 was genetically modified through the insertion of plasmid pZO1502 containing a fusion of gene cry1A(Btk) with gene pat. The event of transgenic Bt11 corn was obtained through the direct transfer of DNA in protoplasts of lineage H8540 of corn, deriving from embryo cells in culture in suspension treated with enzymes for
degradation of cellular wall. It contains the synthetic gene Btk, that comes from Bacillus thuringiensis var. kurstaki, that codifies á-endotoxin Cry 1Ab, that enables the translation of á-endotoxin lethal to insects that ingest these cells, particularly those of Lepidopterus order, and gene pat, derived from Streptomycin viridochromogenes cepa Tu494, and the codifier of the phosphinotricin enzyme N-acetyltransferase (PAT). For
Cry1A(b), the highest expression levels were observed on leaves, with 27 to 33 μg/g of fresh tissue. Levels 5 to 10 times lower were observed in straw tissues, stem and
grains. For PAT, the amount described on leaves is of the order of 44 ng/g of fresh tissue. Half of this value was found on panicles, and 10 times less in style-stigmas. No
allergenic or toxic effects were pointed out coming from genetically modified plants and grains. Genetically modified proteins are degraded by digestion of food, by
gastric fluids and by bacteria present on human being and animals’ gastrointestinal treat. Due to plants bigger production to the attack of insects, and, particularly, of
Bt11 corn spikes, there are less toxins of fungus origin in grains, reducing the possibility of intoxications of human beings and animals. Proteins Cry and PAT do not become volatile, nor are absorbed by the epidermis, and, therefore, it would not be justifiable to evaluate the toxicity of such proteins through inhaling or via dermis.
No unintentional meaningful biological change occurred on the composition, or on the nutritious value of the grain, and of the Bt11 corn sawdust, as a consequence of Cry1A(b), and pat transgene expression, suggesting, then, that Bt11 corn is substantially equivalent in nutritious composition to the respective isogenic hybrid not genetically modified and commercial hybrids of corn. The dispersion of corn seeds is easily controlled, once corn domestication eliminated the ancestral mechanisms of seeds dispersion, and pollen movement is the only effective escape mean of corn plants genes. The horizontal gene flow between Bt and other species, even those that are very related, have almost no probability of occurrence, for sylvan species
related to corn do not naturally occur in Brazil. The coexistence between conventional corns cultivations (improved or creoles), and transgenic cultivation is possible from the agronomic point of view, and for that, one should observe the disposition on Normative Resolution No. 4 of CTNBio. Once B. thuringiensis is a soil microorganisms, the exposition of live organisms, and of the environment to this bacteria, or to any element extracted from it, is an event that abundantly occurs in nature, not resulting in meaningful risk for the soil micro biota. However, even if genic flow occurs between Bt11 corn plants and the creoles varieties, differences of the gene flow in relation to any other existing allele in plants are expected. In sum, the gene or allele will only stay in the population if the gene flow is continuous, with relatively high frequency, and if there is any adaptation advantage. In the Brazilian environment, where sexually compatible native species do not occur, or are known, the risk that Bt11 corn execute or promote the invasion of uncultivated, and cultivated areas does not exist. The ingestion of endotoxin Cry1A(b) by worms of Spodoptera frugiperda, Helicoverpa zea and Ditrea saccharalis with alkaline digestive environment will promote its death through the interaction of the protein with the receptors of cellular surface of intestinal cells of these insects, promoting the opening of the pores, and the invasion of the microorganisms in the intestinal treat. Thus, insects’ death derives from the smotic unbalance promoted by the toxin, and by septicemia deriving from the invasion of microorganisms into the intestinal flora. Meaningful differences were not observed between the populations of ladybugs, carabidae, cincidelidae and spiders, neither of
parasitoid of H. zea, Trichogramma sp., when Bt11 plants were compared to their genetically unmodified isogenic lineage. Bt11 hybrids were efficient for the control of the evaluated plague-lepidopteron, and superior for the profit agronomic parameters of grains and of bitter grains. For the other evaluated agronomic parameters (plants height, insertion height of spikes, date of male and female flowering, note for diseases, percentage of erect plants, kind of grain, grain color), Bt11 hybrids pesented
performance statistically equals to the respective isogenic not GM hybrids, confirming the equivalence of agronomic performance between B11 hybrids, and the non GM isogenic in conditions of the culture cultivation in Brazil. In Brazil, nowadays, there is an indiscriminate use of insecticides, and even a mixture of chemical products, to try to control insects, especially S. frugiperda. The use of Bt technology in Brazil may contribute for the reduction of the use of insecticides, and, consequently, reduce the impacts of the use of such agro toxics in the environment, in human and animal’s health, and it may also indirectly help on the preservation of untargeted organisms’ populations, and benefic insects, facilitating the integrated handling of crop plagues. The use of genetically modified plants resistant to insects present positive repercussions also in the aspects related to the acquisition and use of chemical
insecticides, to meaningfully reduce the pollution provoked by industrial rejects, and by the use of water used on pulverizations, besides avoiding man, food, rivers and
springs contamination deriving from the use, transportation and storage of insecticides. Before the foregoing, one can conclude that the cultivation and consume of Bt11 corn is not the potential cause of meaningful degradation of the
environment, or of risks to human and animal’s health. For these reasons, there are no restrictions to the use of this corn, or its derivatives. The petitioner should conduct
monitoring after the commercial release on the terms of Normative Resolution No.3 of CTNBio. In accordance with what is established on art. 1 of law 11.460, of March 21st,
2007, “it is vetoed the research and cultivation of organisms genetically modified on indigenous lands and areas of conservation units”. In the ambit of competences of art. 14 of Law 11.105/05, CTNBio considered that the request fulfills the norms and the pertinent legislation that aim at guaranteeing biosafety of the environment, of
agriculture and of human and animal’s health.
CTNBio’s TECHNICAL OPINION
I. GMO Identification
Designation of GMO: Bt11 Corn
Petitioner: Syngenta Seeds Ltda.
Species: Zea mays L.
Inserted Characteristics: Resistance to insects of
Lepidoptera order
Method of characteristic introduction: Direct
transformation of protoplasts
Proposed Use: Silage and grains production for human and
animal consume of GMO, and its derivatives.
II. General Information
Corn Zea mays L. is a species from the Gramineae family, Maydae tribe, Panicoideae family. Corn is a separate species within Zea sub-gender, with chromosome number 2n = 20, 21, 22, 24 (26). The sylvan species closer to corn is teosinte, found in Mexico, and in some places in Central America, where it can be crossed with corn cultivated in production fields. The corn produced can also be crossed with the most distant genre Tripsacum. This crossing, however, occurs with great difficulty and results on sterile-male progeny.
Corn history is over eight thousand years old in the Americas, being cultivated since the pre-Colombian period. It is one of the superior plants best scientifically
characterized, being, nowadays, the cultivated species that reached the highest degree of domestication, and only survives in nature when it is cultivated by men(4). Today, there are around 300 races of corn, and within each race, thousands of crops.
Corn is one of the most important sources of food in the world, and is raw material for the production of a wide range of food products, rations and industrial products.
Brazil is the third biggest corn producer in the world with a production of approximately 35 million tons in 2005, behind only of the United States of America (282 million tons), and China (139 million tons)(29). In Brazil, corn is basically planted in two crops (summer plantation, and small crop), and it is cultivated actically all over the national territory, being 92% of the production concentrated in the South (47% of production), Southeast (21% of production) and Center-West (24% of production) (19). In the productive chain of swine, and poultry, approximately 70 to 80% of the corn produced in Brazil is consumed.
It is known that the occurrence of insects in the tropics is bigger than the one in tempered climate regions, and that damages caused are more accentuated. Among the most important corn plagues, one can highlight Spodoptera frugiperda. Cruz et al.(21) estimated that the loss in Brazil, due to the infestation by S. frugiperda was around 400 million dollars per year. From 1999, it was observed an increase on the occurrence of S. frugiperda, and consequently there was increment on the harms. Other species of Lepidoptera order are also important plagues for corn cultivation, such as Helicoverpa zea, and Diatrea saccharalis). It is estimated that these three species may cause damages of up to 34% on corn grains production.
The main insects control measure on corn culture has been the insecticides use. In some areas of the Brazilian center-West regions, for example, dozens of pulverizations
with insecticides are necessary in only one culture cycle. Another plague control measure would be the use of resistant cultivars. The acquisition of cultivars resistant
to insects through classic genetic improvement has not obtained the hoped success. In the case of S. frugiperda, many attempts have been made with limited success(77).
Brazil is the third biggest consumer of agricultural defensives in the world. Nowadays, we have 142 agro toxics registered for corn, 107 only for worms. There are already
many cases of resistance for the constant and indiscriminate use of insecticides in corn culture in Brazil. Besides, one of the factors that affects agriculturists’ health the most in Brazil is the use of agricultural defensives responsible for the intoxication of
a million people every year (2). Bt11 genetically modified corn presents characteristics
that confer resistance, on the same plant, to insects, and to glufosinate of ammonium herbicide, and resists to the main plagues of Lepidoptera Order that affect corn culture
in Brazil, such as S. frugiperda, and H.zea. The genes introduced codify an incomplete form of Bt insecticide protein, obtained from cepa HD-1 of the soil bacteria
Bacillus thuringiensis var. kurstaki (btk), and an enzyme (phosphinotricin-N-acetyl transferase, PAT), that confers tolerance to glufosinate of ammonium herbicide, also
obtained from a soil bacteria, Streptomyces viridochromogenes. Varieties of corn containing Cry proteins have been used in many countries in the world, and
there is no information that hybrids of corn containing cry genes have caused damage to the environment, or to human and other animals’ health. Corn Bt11 is commercialized in 16 countries (Argentina, Australia, Canada, China, European
Union, Japan, Korea, Mexico, Philippines, Russia, South Africa, Switzerland, Taiwan, The United Kingdom, The United States of America, and Uruguay), being commercially
cultivated in the United states (1996), Canada (1996), Japan (1996), South Africa (2003), Philippines (2005), Argentina (2001) and Uruguay (2004). In Brazil many necessary experiments were conducted, and enough studies were made to convince CTNBio’s members about the biosafety of the event in study. In the risk analysis,
the molecular characterization should be considered, taking also in consideration studies carried out regarding the constitutional, agronomic, and physiologic
characterization, of this event itself. The long experience with traditional methods of plants improvement, the experience of over three decades in research, and more than
one decade of commercialization of transgenic varieties in the world, besides the advancement in the knowledge about the structure and dynamics of genomes, indicating if a certain gene, or characteristics is safe, signal that the process of genetic engineering on its own presents little potential for arising unexpected consequences that would not be identified, or eliminated during the process of genetically modified varieties development (8). III. Description of GMO and Expressed Proteins Bt11 corn was genetically modified through the insertion of plasmid pZ01502 containing the fusion of gene cry1A (Btk) with gene pat. This corn expresses gene cry1A(b), derived
from the soil bacteria B. thuringiensis subsp. kurstaki, lineage HD-1.
B. thuringiensis (Bt) is a gram positive bacteria of Bacillaceae family that produces, at the moment of its sporulation, crystalline proteic inclusions. These inclusions contain proteins called á-endotoxins, which nowadays form a family of 300 members, classified in 49 groups(20). They are produced under the form of prototoxins
that are transformed into toxic peptides in the insect’s intestines, through the action of intestinal alkaline pH, and of proteases. The active toxin causes the
destruction of epithelial cells, and the death of the larvae(47,23). B. thuringiensis may be considered the biological agent of greatest potential for the control of
forests, agricultural plague-insects, and vectors of diseases, thanks to the specificity of the á-endotoxins to insects and target-invertebrate, and its innocuousness to
vertebrates and to the environment, including benefic insects and natural enemies(43), making this agent a keycomponent in strategies of integrated handling of
plagues(59). The event of Bt11 transgenic corn was obtained through the direct transfer of DNA(nu) in protoplasts of lineage H8540 of corn, derived from embryo cells in culture in suspension treated with enzymes for degradation of the cell wall, and
it contains DNA sequences inserted into the cell genome, according to the following description. The synthetic gene Btk codifies á-endotoxin cry1Ab. The objective of use of Btk genic cassette is to allow, in vegetable cells, the transcription of RNA, and the translation of lethal á- endotoxin to insects that ingest these cells, particularly
those of the Lepidoptera order, such as the ones of Spodoptera, Helicoverpa and Diatrea genre (61, 17, 34). Modifications on the original sequence of Btk were carried
out in order to alter some codons of preferential use in bacteria for the preferential pattern of vegetable codons, as well as the truncation, that is, the reduction of the
size of the codifying sequence, in order to produce a more effectively toxic version to targeted-insects. The synthetic nucleotide sequence, on the truncation version
did not alter the polypeptide sequence of codified protein on the considered region. The final sequence of gene Btk(1845 pb) illustrated on the process allows for its
immediate comparison with the original sequences of cry1A(b) of B. thuringiensis var.kurstaki available at GenBank with those under the access codes AYB47289, and
AFO59670, among others (65,71,39). Gene Btk is regulated by two nucleotide sequences upstream, constituted by the promoter RNA35S of mosaic virus of cauliflower (35S CaMV), isolated CM1841 with 514 pb, and the intron sequence IV56
of gene of 1S (Adh1S) desidrogenase alcohol of corn, with 412 pb. With these regulating elements the transcription of gene Btk has its potential increased in vegetable cells. As terminating sequence, the cassette of expression has a
terminal region of 270 pb of gene of nopalina-syntase (3’- nos) of T-DNA of Aggrobacterium tumefciens. All the regulating elements of the transcription have a function widely described in scientific literature (45, 35, 48). In
the case of a insecticide toxin without known, or described enzymatic activity, one cannot expect metabolic alterations deriving from the expression of Btk in vegetable cells. The measures of general metabolic contents reinforce the idea
that, if any chemical alteration occurs due to genetic transformation, it is not perceptible through sensible methods of analysis, such as, for example, spectroscopy of near infra-red (NIRS).
Another component of Bt11 corn is gene pat, derived from Streptomycin viridochromogenes cepa Tu494 and codifier of phosphinotricin N-acetyltransferase (PAT) enzyme. The original sequence was modified to reduce the content G/C
and alter the beginning of the translation GTG to ATG, in order to enable, and optimize the syntheses of the original protein. The final version of pat gene has 558 pb. Again, a 551 pb sequence of the promoter 35S of CaMV (isolated Cabbs),
and the intron sequence IVS2 of 178 pb of gene adhS1 of corn were used to promote and increase the transcription of pat gene. Sequence 3’-nos of 220 pb was used as a
terminator element of transgenes. This cassette allows, then, the syntheses of the recombinant protein PAT, capable of chemically inactivate herbicides deriving from
phosphinotricin, such as glufosinate of ammonium, making cells and vegetables that contain it resistant to it. Pat Enzyme has described and well-known activity (32, 57, 70). Bt11 corn has framework of plasmid pUC18, including the origin of replication, and places of recognition of endonucleases that allow the adaptation of sequences. These vector DNA fragments have 1520 pb of extension and there is no evidence that they are expressed on vegetable cells(7). The final version of the plasmid used on the genetic transformation of corn was called pZ01502, and has 6,120 pb, including all the cassettes and elements of DNA described above. This plasmid was destitute from the gene of bacteria resistance to antibiotics derived from penicillin, such as ampicillin (gene ampR), originally present on the parental form pUC18. Hybridizations of Southern blots and amplifications through chain reaction of DNA-polymerase (PCR) were presented to demonstrate the integration of DNA fragment on vegetable
genome, the number of gene copies, the presence, or absence of other DNA elements, and the location of transgene. The results presented corroborate to the statements of the proponent that one transgenic copy was integrated to a long arm of chromosome 8 of the corn originally transformed, and, part of it, transferred to the progenies in
hemizygote, initially, and hemizygote on final versions of parental lineages for the production of hybrids. The location of the insertion was defined by linking molecular
markers of RFLP type (polymorphisms as big as fragments of DNA generated by hydrolysis with endo-nucleases of restrictions). These essays demonstrated, also, the
presence of transgenes cry1A(b), pat, and of the origin of replication of pUC18. Finally, such analysis allow for the conclusion that none of the lineages or hybrids derived from the initial event Bt11 contain gene ampR. Results presented by the proponent regarding the analysis of the presence of cry1A(b) and pat, as well as the pattern of resistance to glufosinate and to S. frugiperda worms, have demonstrated that genes Btk and pat are closely linked, and that both are inherited as loci simple
dominants on Bt11 corn lineage. The segregation data match the Mendelian pattern on the proportion 3:1 for heterozygote progeny. The proof of the presence of recombinant proteins in different vegetables tissues was executed through imunodetection of Cry1A(b) and PAT. For the first protein, higher levels were observed on leaves, with 27 to 33 μg/g of fresh tissue. Levels 5 to 10 times lower were observed
in straw tissues, stem and grains. For PAT, the amount described on leaves is around 44 ng/g of fresh tissue. Half of this value was found in panicles, and 10 times less in
style-stigmas. IV. Aspects Related to Human and Animals’ Health The evaluation of foods safety derived from genetically modified raw material is based on risk analysis, scientific methodology that encompasses the phases of evaluation, management and risk communication. On the risk evaluation phase one looks for the qualitative and quantitative characterization of potential adverse effects, having as base the concept of substantial equivalence for the identification of eventual differences between the new food and its conventional correspondent. The Principle of Substantial Equivalence is key concept on the evaluation process of innocuousness of foods coming from new
technologies (27). To evaluate safety of genetically modified food raw material, or its equivalence to conventional food, it is recommended that four main elements are analyzed, more specifically: (1) parental variety, that is, the plant that originated the new genetically modified raw material; (2) the transformation process, including the characterization of the construction used, and of the resulting event; (3) the product of the inserted gene, and the potential of toxicity and allergenicity, and, finally; (4) the
composition of the new variety deriving fr om the genetic transformation. The group of data of these analyses should allow for the identification and characterization of the
potential adverse effects associated to the new raw material consume, subsidizing the phases of management and risk communication. According to the petitioner, corn Bt11 derives from the transformation of common Zea mays, a species profoundly
characterized, and about which there is solid safety background for human consume. Information about identity, origin and chemical composition have been reported, being
attached to the process publication copy that provides abundant data regarding its composition, highlighting the naturally observed variations on the presence of
nutrients(73). The characterization of Bt11 corn, and its products of expression were extensively analyzed, according to item III of this technical opinion. The state of the art on the evaluation of toxicity preconizes the use of essays of animal experimentation, as scientific form of qualitative and quantitative characterization of potential adverse effects to human health caused by the exposition to environmental
intoxicating substance, or present in foods. Thus, whenever viable, toxicological essays of xenobiotic in experimentation animals are executed, administrated them
through exposition via that allow extrapolating the results observed in animals to humans. This extrapolation allows to establish IDA (Acceptable Daily Ingestion), or Reference Dose that means the dose of this substance to which an individual may expose himself daily without observing negative effects deriving form such exposition.
Thus, the study of protein Btk of corn Bt11 was conducted through acute oral via in rats, besides the digestibility essays. On the essay of simulated digestion, it was
observed that the half-life of the protein is inferior to 30 seconds on the gastric system, and that, in the intestines, the complete chain protein is converted into
the central fragment resistant to tripsine. The toxicity study through acute oral via was conducted in rats, and no harmful effects were observed on any of the evaluated
doses, being 4, 000 mg/kg of body weight the highest dose tested, which is considered the NOEL of the essay, that is, the highest dose in which no harmful effects are observed, estimating thus, DL50 as being superior to 4,000 mg/kg of
body weight. Toxicological classification tables consider low toxicity doses over 2,000 mg/kg of body weight that do not provoke harmful effects on evaluated animals under
adequate experimental conditions.
One can conclude that the absence of effects in this essay was related to the low potential of absorption of protein demonstrated on the study of in vitro digestibility, where one could observe its rapid degradation in the gastric fluid of mammals, with less than 4% of activity after two minutes. This essay demonstrated the stability of the
protein for 19 hours in the intestinal fluid.
The results show that genetically modified corn on the concentration of up to 4,000 mg/kg was incapable of producing acute toxic effects in rats, and that on the
concentration of 11% to 33% on the diet (11g to 33 g/kg of body weight) it was incapable of producing intoxication signs in rats fed for 90 days. The Codes Alimentarius of FAO/WHO(28) uses the following formula for the calculation of IDA = NOEL/FS where:
· IDA is the biggest amount in mg/kg of a chemical substance that can be ingested per day by the human being, during his whole life, and that does not cause
any harm;
· NOEL is the biggest dose of a chemical substance in mg/kg that, if used, does not produce toxic effects on animal species most sensitive to it;
· FS is the safety factor, usually equals to 100 (two order factors 10: the first considering the human being 10 times more sensible than the most sensible
animal species studied, and the second considering the individual variability within the human species).
In this sense, once the biggest amount of genetically modified corn used in toxicity essays (33,000 mg/kg/day in sub-chronic essay in the rat) did not produce toxic
effects, and, considering the impossibility of administrating a bigger amount per day on rats, one can conclude that it is impossible to calculate the NOEL value.
In fact, a rat does not ingest 10g/100g per day of body weight of ration, according to Harkness and Wagner’s description(36), being impossible to feed it with bigger
amount of the product without causing malnutrition due to lack of other normal ration components. Thus, one can understand why there are no IDA values for genetically
modified corn. In other words, the level of its possible toxicity, if it exists, is way beyond the maximum amount ingested by any human or animal that, in practice, one can affirm for its absolute innocuousness.
Brake and collaborators(9) compare the nutritional effects of Bt corn to non modified corn in chicken for slaughter. The results showed that the administration of genetically
modified corn during 35 days did not interfere with the gain of weight, or with the digestibility characteristics of proteins ingested by the chickens. These results were
confirmed, among others, by Taylor et al.(68). Folmer and collaborators(31) compare the nutritional effects of corn Bt with non-modified corn in cattle for slaughter and
concluded that the administration of corn Bt did not modify any parameters that indicate food efficiency, or of gain of weight of the treated animals in relation to those of the control group. Sanden and collaborators(58), during a long term study (8 months) in salmons, reported the lack of alterations in the body development, and on tissues of the fish stomach and intestines.
Proteins Cry and PAT have high molecular weight, 65kD and 30 kD, respectively. So, they are not volatile, nor absorbed by the epidermis, and, for these reasons, it is
not justifiable to evaluate the toxicity of these proteins through inhaling or dermis via. Additionally, the toxicproteins safety of B. thuringiensis have been proved since
the 60’s, with the use of microbial insecticides based on Bt (62, 63, 64), even in organic cultures.
The allergenic potential of proteins Cry 1Ab and PAT was investigated using various criteria, including homology of the sequence of amino acids with allergenic known at the data banks of public domain (Genpept, Swissprot, PIR protein), and no homology was detected(42). On the contrary of known proteic allergenic, studies have demonstrated that proteins Cry1Ab were rapidly inactivated when subjected to
simulated gastric fluids of mammals. Similarly, it was noted that protein PAT was rapidly digested in conditions that reproduce human digestion.
Okunuki and collaborators(53) showed that the degradation of protein Cry1Ab, after being heated is very fast, and, considering its digestibility in human gastric fluids, they
suggested that it should present no allergenic potential, or extremely low one. Batista et al.(5) tested the allergenicity of genetically modified soy and corn in sensitized individuals, comparing it to the one produced by conventional seeds in the same individuals, and showed that the genetically modified products are safe regarding the
allergenic potential. Nakajima and collaborators(50) confirm the previous data when they reported the lack of meaningful levels of specific IgE against Cry1Ab in
patients' serum with food allergy.
Chowdhury and collaborators(16) studied the destination of intrinsic genes (of corn itself), and recombinants in bullcalves fed with Bt11 corn resistant to insects, and noted the presence of intrinsic and recombinant genes in the fluid of rumen, and in the content of the rectus in the period between five to eighteen hours after being fed.
However, recombinant genes were never found in blood cells, or guts, and muscles. Phipps and collaborators(54), in similar work, but with bull-calves fed with ration
containing genetically modified soy (gene cp4-epsps) and Bt corn (gene cry1Ab), found fragments of transgenes in the rumen, and in the duodenal digest. There were no traces of transgene in feces, in the blood, or in the animals’ milk.
Aeschbacher et al.(1), in experiments executed with chicken
fed with hybrid Bt corn, did not find any fragment of transgene in the tissues of the muscles, liver, spleen, other organs, flesh or eggs. A little discussed theme, but with positive impact over human and animal’s health is the possibility of having the
improvement on grains quality, due to the introduction of Cry toxin in corn. Due to the greater protection of plants to insects attack, and, especially, of Bt11 corn spikes,
rotten grains and spikes are extremely reduced when compared to untransformed plants. As a consequence, they diminish the toxins of fungus origin on the grains,
reducing the possibility of humans and animals’ intoxication. Munkvold et al’s(49), and Clements et al’s(18) works in 2003 concluded that B11 corn presented
reduction on the concentration of fungus in the grains. Between grains and sawdust, the parameters evaluated presented a similar profile, and within the amplitude used
as reference by the International Life Sciences Institute Crop Composition(40). The parameter of total grease percentage by dry weight of grains of Bt11 corn was
superior, when compared to the other treatments. However, the fatty acids levels were individually presented within the amplitude published by ILSI(40). The results obtained indicated that no meaningful unintentional biological change occurred on the composition, or on the nutritive value of the grain and of Bt11 corn sawdust, due to the expression of transgenes cry1A(b) and pat, suggesting, then, that Bt11 corn is substantially equivalent in nutritive compositions to the respective isogenic hybrid
not genetically modified and commercial hybrids of corn. From the analysis of residues (proteins) eventually present in food coming from Bt11 corn to be provided to animals and to human beings, one can conclude that none of them have cancer, teratogenic or genotoxic potential. In fact, these proteins do not have any structural similarity with primary or secondary carcinogens, and have no conditions of connecting to human DNA.(15). Finally, the lack of acute, or sub-chronic effects produced by genetically modified corn eliminates, also, any possibility of late neurotoxicity. This toxic effect is exclusive of organophosphorate plaguecide, and does not have any relation to possible residues of Bt11 corn.
Before the foregoing, it is relevant to remind that allergenic or toxic effects coming from genetically modified plants were not found. Genetically modified proteins are degraded by digestion of food, by gastric fluids, and by bacteria present in the gastrointestinal treat of human beings and animals.
V. Environmental and Agronomic Aspects Corn plants are allogamous and annual, of crossed fecundation and widely pollinated with the help of the wind, insects, gravity and other agents. The introduction of genic elements characterized in Bt11 event did not alter the reproductive characteristics of the plant. Therefore, the same chances of crossed fecundation that occurs between hybrids, and not genetically modified lineages of corn, will occur between plants of Bt11 event, and other corn
plants. In Brazil there are no parental species of corn in natural distribution. However, there are populations of creoles corn that can be crossed with genetically modified
corns, in case they are planted in the vicinities.
The risk of passing the transgenes to other individuals in nature, and its consequences, mostly in biodiversity is, without any doubt, one of the direct effects that have called the most attention in case of transgenic. The gene
flow may be horizontal, when the exchange of genetic information happens between animals of different species, genetically distant, or vertical when the passage of
genetic information occurs between individuals of the same species.
The horizontal gene flow between Bt and other species, even those very related, have almost null probability of occurrence. Sylvan species related to corn do not naturally
occur in Brazil. Siqueira and collaborators (66) and Nielsen et al. (51) discuss the possibility of Bt gene of transgenic plant passing to other microorganisms of the
soil. The conclusion is that the probability is very remote. Once B. thuringiensis is a soil microorganism, the exposition of live organisms and of the environment to
these bacteria, or to any element extracted from it is an event that occurs abundantly in nature, not resulting in meaningful risk for soil micro biota. It would be much more
plausible for this gene to pass from B. thuringiensis to other micro-organisms.
The vertical gene flow, at first, has no consequence because most agriculturists do not reuse the collected grains as seeds. The hybrid seeds of F1 generation are
acquired every year. However, there is a small contingent of agriculturists of subsistence that keep creoles varieties. Nodari and Guerra(52) argue that the diversity
of agricultural species composed of creoles cultivars of corn may be threatened by transgenic. However, it is possible to keep these cultivars, for hybrid corn has been
intensively cultivated in Brazil for many decades in the same regions in which most of the creoles cultivars are concentrated and the latter have been kept. On the other
hand, even if gene flow occurs between plants of Bt11 corn, and creoles varieties, it is not expected difference of genic flow in relation to any other allele that exists in
plants. Discussion in this regard is presented by Ramalho and Silva(59). In sum, gene or allele will only remain inthe population if the genic flow is continuous, with a
relatively high frequency, and if there is any adaptation advantage. Additionally, the characteristics introduced into event Bt11 would not bring potentially damaging
consequences to human, animal’s health, or to the environment, due to the considerations made previously, and to the background of safe use in other countries for more than 10 years(12). However, it is necessary to emphasize that the coexistence between conventional cultivars of corn (improved or creoles) and transgenic cultivars of corns is possible from the agronomic point of view(11,46), and one should note the disposition on Normative Resolution No.4 of CTNBio. It is also important to remember that most of indigenous races, creoles populations, ancient and recent cultivars, as well as exotic cultivars of corn are preserved in Brazil by EMBRAPA, as well as in various institutes of germoplasm preservation in the world.
Classical analysis of the genetics presented by the proponent has demonstrated that there is no possibility of distinction between the pollen of Bt11 corn and the pollens
of non-transgenic corns. The results pointed out to the fact that heterozygote corn plants for genes cry1A(b) and pat do not produce progenies excess in crossing-test,
concluding that Bt11 corn pollen is not more competitive, or efficient in fertilization than the conventional pollen. Comparing the pollen concentrations to 1m of source culture under low to moderate winds, it was estimated that, approximately, 2% of pollen is noted at 60m, 1.1% at 200m, and 0.75-0.5% at 500m of distance. At 10 m of a field, in average, the number of pollen grains per area unit is ten times smaller than the one observed at 1m from the border. Therefore, if the established distances of separation developed for the production of corn seeds are observed, it
is expected that the pollen transfer to the adjacent varieties are minimized, being improbable the presence of genetic materials with resistance to insects.
Seeds dispersion is easily controlled, once corn domestication eliminated the ancestral mechanisms of seeds dispersion, and the pollen movement is the only effective
mean of corn plants genes escape, thus, in face of the nature of grains, cobs and corn plants, this vegetable survival is limited to the plantation, and harvest cycle
made by human being, since it is totally dependent on him for the seeds to germinate after being thrashed. The different vegetable tissues and organs do not have
proliferation capacity, being restricted to seeds firmly stuck to the spikes, and protected by straw, that is, only human activity can remove the seeds from the spikes, and guarantee the survival of the vegetable, cycle to cycle.
Thus, corn plants are not invasive plants, and their control is easily executed on crops where cultures rotations are conventional practices, with eventual arise
of voluntary, or spontaneous plants derived from seeds lost during harvest. In the Brazilian environment, where native species sexually compatible with corn do not occur, or are not known, the risk of Bt11 corn execute, or promote the invasion of uncultivated and cultivated areas does not exist.
With expected effects of transgenic expression, an incomplete version of protein Cry1A(b) is expressed on vegetable tissues. Lepidopterus insects S. frugiperda , H.
zea and D. saccharalis are particularly susceptible to the action of this class of á-endotoxins, for they have digestive treat with alkaline pH, what promotes the
solubilization of proteic crystals, and the intestinal receptors specific to them. This endotoxin ingestion by worms with alkaline digestive environment will promote the
death of the insects through the interaction of the protein with intestinal receptors of cellular surface, promoting the opening of the pores, and the invasion of
microorganisms of the intestinal treat. Thus, the insects’ death derives from the osmotic unbalance promoted by the toxin, and by septicemia deriving from the invasion of the intestinal flora by microorganisms(10). One of the advantages of transgenic plants resistant to insects expressing genes that codify á-endotoxins, or the
microbial preparations, when compared to chemical insecticides, is the high specificity to target-species. In fact, no differences were observed among populations of
Dermaptera: Forficulidae, Coleopteran: Anthocoridae, Carabidae, Cincidelidae and Araneae. In relation to eggs parasitism of H. zea by Trichogramma sp. (Hymenoptera:
Trochogrammatidae), no meaningful differences were observed either when compared to Bt11 plants with their isogenic lineage not genetically modified(30). The results inforce observations made in other countries and cultures where field studies showed that the abundance and activity of untargeted insects (predators and parasitoids) were similar when plants genetically modified with Bt were compared to non-genetically modified plants. In contrast, crops whose control is made through chemical methods, negative effects are normally observed on the biological control of plagueinsects. Before the foregoing, one can conclude that the use of Bt plants, and the consequent reduction on the applications of insecticides tend to favor the presence of predators insects and parasitoids of plague-insects(57). In relation to target-insects, this event was tolerant to the attack of H.zea, almost no damage occurred on spikes, and to the attack of S. frugiperda. In severe infestation conditions of S. frugiperda, the proponent demonstrated that hybrids of Bt11 corn presented productivity extremely higher than that the one of its non-transgenic isogenies.
In fields experiments carried out in 2000 in Uberlândia, MG, Bt11 corn also showed a noted effect over Mocis latipes (plague of Lepidoptera order that feeds from leaves).
According to analysis of factorial variance of the data presented by the proponent, no difference was observed between the hybrids derived from original elite lineages
and the derivatives of Bt11 converted lineages selected for the aspects of productivity, humidity on harvest, putting roots on the ground, spikes height, plants height, and
thermal units for adornment, or dehiscence of pollen grains. However, meaningful differences were described between the original elite-lineages, and the conversions
Bt11 for the characteristics of putting the stem on the ground, and integrity note. Bt11 corn presented smaller stem breakage than the non-transgenic hybrids, due to the fact that the former is less susceptible to damages on the leaves and on the stem, due to the smaller incidence of plague-lepidopteron. In relation to differences between
grains produced by Bt11 corn, and by equivalent conventional corn, the analysis results of spectroscopy of near infra-red (NIRS) have demonstrated that there are no
differenced in relation to non-transgenic grains for density, weight of 100 grains, grains size, amid percentage, protein percentage, oil percentage, and fiber
percentage.
Agronomic parameters, and the efficacy on plaguelepidopteron control of Bt11 corn hybrids were compared to isogenic lineages in essays conducted in 5 places:
Uberlândia-MG, Ituiutaba-MG, Iraí de Minas-MG, Campo Mourão-PR and Pinhalzinho-SC, in the agricultural harvest of 2005/06. Plants structure, spikes insertion height, male and female flowering date, note for diseases, percentage of erect plants, kind of grains, gains color, humidity content, profit, and rancid grains, were the parameters
studied on the agronomic evaluations. For the study of efficacy of the event Bt11 in the control of lepidopteronplague damage of S. frugiperda, of D. saccharalis, and of
H. zea were evaluated. Bt11 hybrids were efficient for the control of the evaluated lepidopteron-plague, as well as superior for the agronomic parameters grains profit and rancid grains. According to presented information the favorable differential of performance was mainly related to the efficient protection against the attack of the plagues studied. For the other evaluated agronomic parameters Bt11
hybrids presented performance statistically equals to the respective non GM isogenic hybrids. These results confirm the equivalence of agronomic performance between Bt11 hybrids, and the non GM isogenies in cultivation conditions of the culture in Brazil. In Brazil nowadays, there is indiscriminate use of insecticides, and even mixture of chemical products, trying to control insects, especially S. frugiperda. With the massive application of these chemical products, an agricultural desert is created in certain regions of Brazil, for the natural enemies of plagues are the first to
be eliminated. The frequent application of chemical insecticides contributes for the degradation of the environment, environmental pollution and break of all the ecosystem in corn culture, and even in other cultures in rotation. With the adoption of genetically modified plants resistant to insects, the reduction of insecticides has
been considerable in countries that have adopted the technology for more than ten years. For example, in the United States, producers have obtained reduction of more
than 8,000 tons of insecticide active ingredient only in 2001(14,34,33). In China, the applications of insecticides were reduced in an average of 67%, and the reduction in
volumes of insecticide active ingredients was reduced in 80%(38). In South Africa the reductions were around 66%(41). Before the foregoing, one can consider that the
use of Bt technology in Brazil may contribute for the reduction of the use of insecticides and consequently, reduce impacts of use of these agro toxic in the
environment, in the human and animal’s health. What’s more, the use of Bt technology may have positive impact on the preservation of populations of untargeted organisms and benefic insects, facilitating the integrated handling of
crop plagues(69, 37,6). Additionally, the adoption of technologies that reduce pulverization of chemical products in crops may favor acquiring secondary benefits, such as the reduction of use of raw-material on the production of
agro toxics, on the conservation of fuel used to produce, distribute and apply such agro toxic, and for the elimination of use necessity and discard of agro toxic
cartons(44). VI. Restriction to the use of GMO and its derivatives:
Studies presented by the petitioner demonstrated that therewas no meaningful difference between the hybrids of corn derived from unmodified lineages and Bt11 corn in relation to agronomic characteristics, such as productivity, harvest
humidity, putting the root on the ground, spike height, plant height, and others. Besides, there were no meaningful differences in the reproduction way, dissemination or capacity of survival of the genetically modified corn in relation to lineages of unmodified corn. All the evidences presented in the process, and in bibliographic references such as Schuler et al.(60), of Maagd et al. (22), Candas and collaborators(13), Brookes et al. (11), Broderick et al. (10), Sanden et al. (58), Okuniki et al. (53), among others, confirm the risk level of the transgenic variety as equivalent to the non-transgenic varieties in face of the soil micro flora, to untargeted vertebrate and invertebrate animals, as well as to other vegetables, and to human and animal health. Thus, the cultivation and consume of Bt11 corn are not potentially causing meaningful degradation of the environment, or risks to human and animal’s health. For
these reasons, there is no restriction to the use of this corn, or its derivatives.
After ten years of use in different countries, no problem was detected for the human and animal’s health, or for the environment that may be attributed to transgenic corn. It is necessary to emphasize that the lack of negative effects resulting from transgenic plants cultivation of corn does not mean that they cannot happen. Zero risk to absolute
safety does not exist in the biological world, however, there already exists an accumulation of trustworthy scientific information , and a safe background of ten years
use that allows us to affirm that Bt11 corn is as safe as its conventional versions. Thus, the petitioner should conduct monitoring after the commercial release on the
terms of Normative Resolution No. 3 of CTNBio. The vertical gene flow for local varieties (called creoles corns) of open pollination is possible, and presents the
same risk caused by commercial genotypes available in the market (80% of conventional corn planted in Brazil come from commercial seeds that went through a process of genetic improvement). The coexistence of conventional corns cultivations (improved or creoles), and transgenic cultivations of corns is possible from the agronomic point of view(11, 46), and should follow the disposition on Normative Resolution No. 4 of CTNBio. VII. Considerations about particularities of different
regions of the Country (subsidies to the inspections organs):
In accordance with what is established on art. 1 of Law
11.460, of March 21st, 2007, “it is vetoed the research and cultivation of organisms genetically modified on indigenous lands and areas of conservation units”.
VIII. Conclusion
Considering that Bt11 corn derives from the transformation of common corn Z. mays, species profoundly characterized, and about which there is solid safety background for human and animal consume, and that the transformation process gave place to the insertion of a sole copy of the fragment of DNA containing the genetic constructions with genes pat and Btk.
Considering that the safety of corn containing gene pat was exhaustively analyzed by CTNBio on process 01200.005154/1998-36, and, moreover, that on Technical
Opinion 987/2007 all aspects related to biosafety of Liberty Link corn were approached. Considering also that:
1. Corn is the species that reached the highest degree of domestication among cultivated plants, being able to survive in nature without human intervention.
2. There is no sylvan species in Brazil with which corn can be crossed, since the closer sylvan species to corn is teosinte, found in Mexico and in some places in Central
America, where it can be crossed with corn cultivated in production fields.
3. Protein Cry1Ab was detected in low levels of analyzed tissues, and presented great susceptibility to digestion in simulations of gastric fluids, not demonstrating acute
toxicity in mammals, or similarity with known allergens.
4. Due to the greater protection of plants to insects’ attack, particularly, of Bt11 corn spikes, rotten grains and spikes are meaningfully reduced when compared to
untransformed plants, consequently, there is reduction of toxins of fungus origins in grains, diminishing the possibility of intoxication of humans and animals.
5. No unintentional meaningful biological change occurred on the composition, or on the nutritious value of the grain and of the Bt11 corn sawdust, due to Cry1A(b) and pat transgene expression, suggesting, then, that Bt11 corn is substantially equivalent in nutritious composition to the respective isogenic hybrid not genetically modified, and to commercial corn hybrids.
6. DNA molecule is a natural food component, not presenting any evidence that such molecule may have adverse effect to men when ingested in food in acceptable quantities (no direct toxic effect). 7. There is no evidence that intact genes of plants may be transferred and functionally integrated to human genome, or
to other mammals exposed to this DNA, or foods manufactured with these elements(16). 8. The petitioner answered to all the questionings postulated on Normative Instruction No. 20 of CTNBio, and none of the questions indicate that this corn may present adverse effects on human or animal food.
9. There is no risk of Bt11 corn to execute or promote invasion of uncultivated areas.
10. B. thuringiensis may be considered the biological agent of greatest potential for the control of forests, agricultural plague-insects, and vector of diseases, thanks
to the specificity of endotoxins to insects and targetinvertebrate, and its innocuousness to vertebrates and environment, including benefic insects and natural enemies, making this agent a key-component in strategies of integrated handling of plagues. 11. B. thuringiensis cultures are registered in the National Health Surveillance Agency – ANVISA under different formulations for the application in 30 kinds of vegetable cultures for food use.
12. Bio-pesticides based on toxin are widely used as an alternative to chemical insecticides in terms of safety to non-targeted organisms, and when the development of resistance to chemical insecticides occurs. 13. Meaningful differences were not observed between the populations of ladybugs, Carabidae, cincidelidae and
spiders, as well as parasitoid of H. zea, Trichogramma sp., when plants Bt11 are compared to their isogenic lineage not genetically modified.
14. One of the advantages of transgenic plants resistant to insects expressing genes that codify endotoxins, or microbial preparations, when compared to chemical
insecticides, is the high specificity to target-species. 15. The use of Bt technology in Brazil may contribute for the reduction of the use of insecticides, and,
consequently, reduce the mpacts of the use of such agrotoxics in the environment, in human and animal’s health, and it may also indirectly help on the preservation of nontargeted organisms populations and benefic insects,
facilitating the integrated handling of crop plagues. 16. The use of genetically modified plants resistant to insects present positive repercussions also in the aspects
related to the acquisition and use of chemical insecticides, to meaningfully reduce the pollution provoked by industrial rejects, and by the use of water used on
pulverizations, besides avoiding man, food, rivers and springs contamination deriving from the use, transportation and storage of insecticides.
17. The coexistence among cultivations of conventional corns (improved or creoles) and transgenic cultivations of corns is possible from the agronomic point of view, and one should observe the disposition on Normative Resolution No.
4 of CTNBio. 18. Comments, opinions, suggestions and documents resulting
from the Public Hearing that took place on March 20th, 2007 did not present relevant scientific fact, substantiated by scientific evidences that compromise environmental safety of human and animals’ health of corn Bt11.
19. Attachment III of Cartagena Protocol about Biosafety (Decree 5.705, of February 16th, 2006) says that risks associated to live organisms modified, or to products
derived from them, to wit, benefited materials that have as origin a live modified organism, containing new detectable combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered on the context of risks presented by the nonmodified receptors or parental organisms in the probable receptor environment.
20. The historical use of this transgenic variety in the world reveals a great accumulation of trustworthy scientific information that indicate that this variety is
as safe for the environment, and for human and animal health, as the varieties of hybrid corns that have been being used.
21. After ten years of use in different countries, no problem was detected for human, animal’s health, or to the environment that may be attributed to transgenic corns. It
is necessary to emphasize that the lack of negative effects resulting of corn transgenic plants does not mean that they may not happen. Zero risk and absolute safety does not exist in the biologic world, although there already exist an accumulation of trustworthy scientific information and a safe background of ten years of use that allows us to declare that corn Bt11 is as safe as conventional versions.
Thus, the petitioner should conduct monitoring of postcommercial release on the terms Normative Resolution No. 3 of CTNBio.
Before the foregoing, and considering the international criteria accepted on the process of risk analysis of genetically modified raw-material, it is possible to
conclude that Bt11 corn, derived from MON810 lineage, is as safe as its conventional equivalent. CTNBio thinks that the cultivation and consume in commercial scale of Bt11 corn are activities that do not potentially cause meaningful degradation of the environment or aggravations to human and animal health. The use restrictions of the GMO in analysis and its derivatives are conditioned to disposition on Normative Resolution No. 03 and Normative Resolution No. 04 of CTNBio.
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36. HARKNESS, J.E.; WAGNER, J.E. 1993. Biologia e Clínica
de Coelhos e Roedores. São Paulo: Roca, 3.ed.p.49.
37. HEAD, G.; FREEMAN, B.; MINA, B.; MOAR, W.; RUBERSO, J.;
TURNIPSEED, S. 2001. Natural enemy abundance in commercial
Bollgard and conventional cotton fields. Proceedings of the
Beltwide Cotton Conference 2: 796-798. Memphis; National
Cotton Council.
38. HUANG, J.; ROZELLE, S.; PRAY, C.; WANG, Q. 2002. Plant
biotechnology in China. Science 295: 674-676.
39. HUANG, Z.; GUAN, C.; GUAN, X. 2004. Cloning,
characterization and expression of a new cry1Ab gene from
Bacillus thuringiensis WB9. Biotechnol. Lett.26: 1557-1561.
40. ILSI. 2004. Nutritional and safety assessment of foods
and feeds nutritionally improved through biotechnology.
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41. ISMAEL, Y.; BENNETT, R.; MORSE, S. 2002. Bt cotton,
pesticides, labour and health: a case study of smallholder
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Ravello, Italy.
42. KEEK, P.J.; MITSKY, T.A. 1994. Comparative alignment of
insecticidally-active B.t.k. HD-73 protein (b.t.k. protein)
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arthropod species to Bacillus thuringiensis. In: BURGES,
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Molecular traditional methods

Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:

The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons.
Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

The BT11 line of corn (Zea mays) was developed through a specific genetic modification to be ECB (Ostrinia nubilalis) resistant and tolerant to glufosinate ammonium herbicide. The novel variety produces a truncated version of the insecticidal protein, CryIA(b) derived from Bacillus thuriengensis, and an enzyme, phosphinothricin N-acetyl transferase (PAT), from Streptomyces viridochromogenes. Deltaendotoxins, such as the CryIA(b) protein expressed in BT11 corn, act by selectively binding to specific sites localized on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ion flow and thereby cause paralysis and death.

CryIA(b) and related endotoxins are insecticidal only to lepidopteran insects and their specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins. Phosphinothricin containing herbicides, such as glufosinate ammonium, act by inhibiting glutamine synthetase resulting in the accumulation of toxic levels of ammonia. The PAT enzyme detoxifies phosphinothricin by acetylation into an inactive compound. The modified corn line is protected from ECB damage and permits farmers to use phosphinothricin-containing herbicides for weed control in the cultivation of corn.

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Date of authorization:

15/08/1996

Scope of authorization:

Food and feed

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Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.
The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations (see Figure 1). Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale.
The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.

Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:

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Regulations on Safety of Agricultural Genetically Modified Organisms (hereafter referred to as the Regulations)was promulgated by Decree No. 304 of the State Council of the People’s Republic of China on May 23, 2001. Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, Implementation Regulations on the Safety of Import of Agricultural Genetically Modified Organisms and Implementation Regulations on Labeling of Agricultural Genetically Modified Organisms are formulated by Ministry of Agriculture on January 5, 2002 in accordance with the Regulations.
The State Council establishes a system of joint ministry conference for the safety administration of agricultural GMOs. The joint ministry conference for the safety administration of agricultural GMOs shall be composed of officials from relevant departments of agriculture, science and technology, environment protection, public health, foreign trade and economic cooperation, inspection and quarantine, and be responsible for the decision-making and coordination of major issues with respect to the safety administration of agricultural GMOs.
According to Article 9 of the Regulations, a national biosafety committee (NBC) shall be established and in charge of safety assessment of agricultural GMOs. The NBC shall be composed of experts who are engaged in biological research, production, processing, inspection and quarantine with respect to agricultural GMOs, as well as experts in the fields of public health and environmental protection. The office term of the NBC shall be three years. Ministry of Agriculture is responsible for the nationwide supervision and administration of the safety of agricultural GMOs. The Ministry of Agriculture sets up an office for biosafety administration of agricultural GMOs(OBA), which will be in charge of the administration of the safety assessment of agricultural GMOs. OBA is Affiliated to the Department of Science, Technology and Education.

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GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.

Syngenta developed a corn line resistant to the Asiatic Corn Borer (ACB) larvae, a periodic pest of corn in the Philippines. This corn line referred to in this document as Bt 11, was developed to provide a method to control yield losses from insect feeding damage caused by the larval stages of ACB, without the use of conventional pesticides. . In addition, Bt 11 was transformed with a gene that confers tolerance to the herbicide glufosinate ammonium.

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Date of authorization:

19/07/2013

Scope of authorization:

Food and feed

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Summary of the safety assessment:

Syngenta Philippines, Inc. submitted applications to the Bureau of Plant Industry (BPI), requesting for biosafety permits under Administrative Order (AO) No. 8 for Bt 11 Corn for direct use as food, feed, or for processing and for propagation, respectively. Bt11 has been genetically modified for insect resistance and herbicide tolerance.
Corn Bt 11 has been evaluated according to BPI’s safety assessment by concerned agencies of the Department of Agriculture (DA): [Bureau of Animal Industry (BAI) and Bureau of Agriculture, Fisheries, and Product Standards (BAFPS)], and a Scientific Technical Review Panel (STRP). The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological issues and nutritional issues associated with the modified corn
The petitioner/applicant published the application for direct use in two widely circulated newspapers for public comment/review. BPI received no comment on the petition during the 30-day comment period.
Review of results of evaluation by the BPI Biotech Core Team, in consultation with DA-Biotechnology Advisory Team (DA-BAT), completed the approval process.

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The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops.
Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community.
The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power.
The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment.
The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding
A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI)
A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

United States of America

Name of product applicant:

Syngenta

Summary of application:

CryIAb

Bacillus thuringiensis subsp. kurstaki (Btk)

Resistance to European corn borer

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Date of authorization:

01/08/1996

Scope of authorization:

Food and feed

Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):

The United States is currently in the process of populating this database.
The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment.
FDA
In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology).
In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.
EPA
The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA.
PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA.
When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed.
In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.